FDA’s sharing of grand jury information comes under criticism

An office inside the Food and Drug Administration routinely shares details internally about criminal matters pending before grand juries, a step some lawyers say may run afoul of rules meant to safeguard investigations.

An office inside the Food and Drug Administration routinely shares details internally about criminal matters pending before grand juries, a step some lawyers say may run afoul of rules meant to safeguard investigations.

FDA agents send updates about anticipated grand jury testimony and indictments to more than two dozen people, many of whom have nothing to do with the case, emails from the agency’s Office of Criminal Investigations, OCI, show.

The e-mails, known as “headquarters alerts,” give FDA brass a heads up about expected actions inside or outside of court – such as arrests, the execution of search warrants, grand jury indictments or jury verdicts – so managers can prepare for possible press coverage.

Managers in the Rockville-based criminal investigations office require agents in the field to send these emails, internal communications and interviews show.

This secrecy is designed to protect the integrity of the government’s investigation and the rights of subjects facing possible indictment.

Under rule 6(e), the disclosure of a grand jury matter may only be made to government employees whose names are on a list on file in the court where the grand jury is impaneled. Only those deemed “necessary to assist” government lawyers can be designated, and each is to be advised to keep the matter confidential.

The FDA’s “headquarters alerts” emails are typically sent to dozens of people inside the criminal office, according to copies seen by Reuters. Recipients include office managers, a training coordinator and a public affairs official.

Others receive them even if the case doesn’t touch upon their subject expertise. Agents who specialize in food and tobacco receive information about drug cases, for instance.

In an interview, OCI Director George Karavetsos said he does not believe the emails violate grand jury secrecy rules.

“Discussing those things that are going to happen prospectively or have not yet happened, meaning that they may or may not happen, don’t necessarily violate 6(e),” he said. “I have not seen anything that has violated 6(e).”

A person who knowingly or willfully violates the rule can be held in contempt by a federal court.

The FDA Office of Criminal Investigation’s handbook says only people whose names have been filed with the court are allowed to know “about the jury’s activities, such as whether the grand jury has issued a subpoena to someone.”

Even the mere “fact” that a grand jury has been convened or issued subpoenas should be disclosed on a need-to-know basis through the proper channels, it says. “Neither FDA colleagues nor supervisors may be advised of the substance of grand jury activities unless they have been designated.”

Adam Kurland, a former federal prosecutor who teaches criminal law at Howard University, said it is “mind-boggling” that FDA “bureaucrats who should know better” are internally sharing details about who is testifying and what counts are being considered.

Unless every single person on the e-mail list is properly designated, he said, the FDA is likely in violation of the rules. “It sounds like the FDA PR machine has gotten ahead of itself,” he said.

Solomon Wisenberg, a defense attorney at Nelson Mullins Riley & Scarborough LLP, called the FDA’s denial that it was breaking rules “bulls—” and said he felt “almost any federal judge” would agree it is improper.

Some attorneys disagree, saying the FDA’s actions, while questionable, may not necessarily violate rules. Court districts vary in how strictly they interpret grand jury secrecy rules.

“The expectation that certain information is going to be presented to a grand jury is not necessarily 6(e),” said James Felman, a defense attorney with Kynes, Markman & Felman.

Among the e-mails in question: One dated January 12, 2016 containing an attachment saying a special agent in Puerto Rico planned to “present two indictments to a federal grand jury” the next day against two men for their alleged role in a prescription drug diversion scheme and the sale of physician drug samples. The arrests of the two men, it says, were tentatively slated for January 14, the day after the indictment was expected to be returned.

Another email, sent January 20, 2016, discloses that a postal inspector was slated to testify five days later before a grand jury in support of an indictment against Averill Perkins for conspiring to distribute misbranded, foreign-sourced Tramadol.

An attachment with the e-mail goes into greater detail, naming an alleged co-conspirator expected to be indicted “in the near future” by a grand jury in a different district.

Perkins was not indicted until seven days later, court records show. There is no public record of any co-conspirator indictment.

Jake Watson, an attorney for Perkins, said he was “bothered” to learn the FDA had internally shared information before an indictment was filed.

Such concerns are not new.

In 2011, agents told the Health and Human Services Inspector General that the FDA did not have built-in restrictions in the office’s online case management system to prohibit access to grand jury materials, and that managers in headquarters could access information without being designated, according to a May 2012 report by the inspector general.

The report also said the FDA’s New York office did not follow policy by restricting access to grand jury information to the office’s number one and two ranking officials. At the time, the FDA’s response did not address the concerns.

Reuters examined the FDA’s handling of grand jury information as part of a broader look at the OCI, a little-known unit where agents carry guns and investigate crimes. The office has spent thousands of hours investigating doctors who purchased imported misbranded drugs. Yet more than half of all OCI cases from 2008-2015 were closed without action, Reuters found.

Critics contend OCI’s approach protects drug makers as much as consumers. The FDA said it follows leads from all sources to ensure dangerous drugs do not infiltrate the market.